BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8750925 · Received July 1, 2019

    Report

    Report Number
    1645337-2019-14800
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001775
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 7/29/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEFLATION OF THE IMPLANT. DURING EVALUATION OF THE SAMPLE SOME PARALLEL LINES OF SHELL WEAR WERE OBSERVED ON THE ANTERIOR ASPECT SUGGESTION IN VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING WAS PERFORMED AND IT REVEALED A TEAR AT THE UNION BETWEEN THE SHELL AND VALVE. MICROSCOPIC EXAMINATION WAS PERFORMED AND NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. POSSIBLE CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING EVENTS: EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA TO THE BREAST. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5820661, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE PROSTHESIS (RIGHT) AND A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS (LEFT) WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543369 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5820661 00081317001775

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention